Federal Register notice: FDA determines that Mayne Pharma Internationals Doryx MPC (doxycycline hyclate), delayed-release tablets, 60 mg, were not wit...
FDA issues Warning Letters to all three duodenoscope manufacturers for failing to comply with a 2015 agency order to conduct postmarket surveillance s...
Federal Register notice: FDA makes available a draft guidance entitled Proprietary Names for New Animal Drugs.
FDA approves two ANDAs from Cipla Limited and Aurobindo Pharma for the first generic versions of Amgens Sensipar (cinacalcet hydrochloride) tablets fo...
FDA approves a Valencia Technologies IDE to conduct a 20-site pivotal clinical trial using its eCoin device technology to treat overactive bladder.
FDAs Gastrointestinal Drugs Advisory Committee votes unanimously (15-0) to support approval of a Pfizer supplemental NDA for Xeljanz (tofacitinib) to ...
FDA grants MiMedx Group a regenerative medicine advanced therapy designation for micronized amniotic tissue, AmnioFix Injectable, and its use in treat...
In an address to the Alliance for a Stronger FDA, CDRH director Jeff Shuren says the Centers real world evidence initiative is a top priority and will...